Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
FDA 510(k) clearance K171961 · decided 2017-11-17
Clearance details
- K-number
- K171961
- Device name
- Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
- Applicant
- Xiamen Compower Medical Tech. Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-30
- Decision date
- 2017-11-17
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Xiamen, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Xiamen Compower Medical Tech. Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.